A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck

Trial Information

A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head and Neck

OBJECTIVES:

Primary

- To screen for an indication that the addition of vandetanib to chemoradiotherapy may
prolong disease-free survival as compared to a combination of chemoradiotherapy in
patients with resected, high-risk stage III or IV head and neck squamous cell
carcinoma.

Secondary

- To determine whether this treatment regimen can be delivered safely and successfully
following surgical resection for advanced head and neck cancer.

- To estimate the locoregional progression, distant metastasis, and overall survival
rates for patients treated with this regimen.

- To examine the distribution of selected biomarkers that may include but are not limited
to EGFR (epidermal growth factor receptor, total and phosphorylated), E-cadherin, pMAPK
(phosphorylated mitogen-activated protein kinase), pAKT, Stat-3 (signal transducer and
activator of transcription 3), Ki-67, COX-2 (cyclooxygenase 2), and cyclin B1
(G2/mitotic-specific cyclin-B1)expression in this group of patients and to explore the
potential correlation between these markers with the ultimate treatment outcome

- Arm I: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive
cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.

- Arm II: Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour
once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib
once daily beginning 14 days prior to the start of radiotherapy.

In both arms, treatment continues for 6 weeks in the absence of disease progression or
unacceptable toxicity.

Tissue samples from all patients are collected and reviewed. Tissue from patients with
oropharyngeal carcinoma is analyzed for human papillomavirus.

After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 4 years, and then annually thereafter.

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed squamous cell carcinoma of the head and
neck, including any of the following subtypes:

- Oral cavity

- Oropharynx

- Larynx

- Hypopharynx

- Stage III or IV disease (no distant metastases)

- No cancer of the lip, nasopharynx, or sinuses

- Must have undergone gross total resection* (with curative intent) within 3-6 weeks of
registration, with pathology demonstrating 1 or more of the following risk factors:

- Histologic extracapsular nodal extension

- Invasive cancer seen on microscopic evaluation of the resection margin, when all
visible tumor has been removed NOTE: *Tonsillar cancer patients who undergo
transoral excision of all gross tumor are eligible if the patient has formal
neck dissection confirming histologic extracapsular nodal extension

- Prior allergic reaction to cisplatin or vandetanib or derivatives similar to these
drugs

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior systemic chemotherapy for this disease (prior chemotherapy for a different
cancer allowed)

- No prior radiotherapy to the head and neck area that would result in overlap of
radiotherapy fields

- More than 30 days since prior investigational agents

- More than 3 weeks since prior major surgery and recovered

- More than 2 weeks since prior and no concurrent medications that induce Torsades de
Pointes

- More than 2 weeks since prior and no concurrent known potent inducers of CYP3A4
(Cytochrome P450 3A4), including rifampicin, phenytoin, carbamazepine, barbiturates,
and Hypericum perforatum (St. John wort)

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